A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

NCT06533098 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 80202135FNAIT30032023-509434-19-00
• Study Type: interventional
• Target: 50
• Locations: 6 countries
• Sites: 24

Brief Summary

The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Conditions

Thrombocytopenia, Neonatal Alloimmune

Outcome Measures

Primary Outcomes (1)

• Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L

  Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count \<30\*10\^9/L will be reported.

  Up to 1 Week post birth

Secondary Outcomes (19)

• Platelet Count at Birth in a Neonate

  At birth

• Neonate/Fetus with Outcome of Death

  Up to 1 Week post birth

• Neonate with Platelet Count at Birth <10*10^9/L

  At birth

• Neonate with Platelet Count at Birth <30*10^9/L

  At birth

• Neonate with Platelet Count at Birth <50*10^9/L

  At birth

Study Arms (2)

Arm 1: Nipocalimab

EXPERIMENTAL

Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive nipocalimab starting at gestational age (GA) week 13 to 18 until before delivery.

Drug: Nipocalimab

Arm 2: Intravenous Immunoglobins (IVIG)

EXPERIMENTAL

Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive IVIG from GA week 12 for high-risk pregnancies or GA week 20 for standard-risk pregnancies. Additionally, prednisone will be added per study protocol. Participants will be gradually tapered off prednisone after delivery as per investigator judgement or maternal participant tolerance.

Drug: Intravenous immunoglobulins (IVIG); Drug: Prednisone

Interventions

Intravenous immunoglobulins (IVIG) DRUG

IVIG will be administered intravenously.

Arm 2: Intravenous Immunoglobins (IVIG)

Nipocalimab DRUG

Nipocalimab will be administered intravenously.

Also known as: JNJ-80202135, JNJ-86507083

Arm 1: Nipocalimab

Prednisone DRUG

Prednisone will be administered orally.

Arm 2: Intravenous Immunoglobins (IVIG)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant and an estimated gestational age from week 13 to 18 at visit 1
• Has a history of greater than or equal to (\>=) 1 prior pregnancy with FNAIT based on medical records including: a) neonatal platelet count less than (\<) 150\*10\^9/Liter with no fetal/neonatal intracranial hemorrhage (ICH) or severe fetal/neonatal hemorrhage (standard-risk) OR b) fetus/neonate with ICH or severe hemorrhage in a fetus/neonate (high-risk)
• Current pregnancy with presence of maternal anti-HPA-1a and/or anti-HPA-5b alloantibody and positive fetal HPA-1a and/or HPA-5b genotype as confirmed by cell-free fetal DNA in maternal blood
• Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
• For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit

You may not qualify if:

• Currently pregnant with multiple gestations (twins or more)
• History of severe preeclampsia in a previous pregnancy
• History of myocardial infarction, unstable ischemic heart disease, or stroke
• Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, to IVIG or to prednisone
• Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (24)

The University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

UC Davis School of Medicine

Sacramento, California, 95817, United States

RECRUITING

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Advocate Children's Hospital

Park Ridge, Illinois, 60068, United States

RECRUITING

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Oregon Health And Science University

Portland, Oregon, 97239, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

Medizinische Universitaet Graz

Graz, 8036, Austria

RECRUITING

Medical University Vienna

Vienna, 1090, Austria

RECRUITING

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, 35392, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Universitatsklinikum Jena

Jena, 07747, Germany

RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

RECRUITING

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

RECRUITING

Instytut Centrum Zdrowia Matki Polki

Lodz, 93 338, Poland

RECRUITING

Instytut Matki i Dziecka

Warsaw, 01 211, Poland

RECRUITING

Panstwowy Instytut Medyczny MSWiA w Warszawie

Warsaw, 02 507, Poland

RECRUITING

Birmingham Women's Hospital

Birmingham, B15 2TG, United Kingdom

RECRUITING

Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital

Liverpool, L8 7SS, United Kingdom

RECRUITING

Queen Charlotte's and Chelsea Hospital

London, W12 0HS, United Kingdom

RECRUITING

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

RECRUITING

Related Publications (1)

• Bussel J, Stegmann B, Baker P, Oey A, Jiang Y, Zaha R, Van Valkenburgh H, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Open-Label Study of Nipocalimab or IVIG and Prednisone in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2025 Dec 12. doi: 10.1055/a-2753-9323. Online ahead of print.

  PMID: 41290206 DERIVED

MeSH Terms

Conditions

Thrombocytopenia, Neonatal Alloimmune

Interventions

Immunoglobulins, Intravenous; Prednisone

Condition Hierarchy (Ancestors)

Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: February 10, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 5, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (4); DE (4); AU (2); PL (3); US (10); NL (1)